Containment, Dermatology, FDA Approval and Medicine

Filsuvez Topical Gel Gets FDA Approval for Epidermolysis Bullosa

XTalks

JANUARY 2, 2024

Filsuvez topical gel is a sterile botanical drug product designed for topical use, containing birch triterpenes within an oil base. For instance, Vyjuvek , the first FDA-approved gene therapy for DEB, is priced at $24,250 per vial. Regarding the price of Filsuvez, it has not yet been publicly disclosed by the company.

FDA Approval

FDA Approval Gene Therapy Gene Trials

FDA approves Octapharma’s Octagam® 10% for adult dermatomyositis

Bioengineer

JULY 20, 2021

FDA approval based on positive results of international, multi-center ProDERM study. “The FDA approval of Octagam® 10% as a safe and effective treatment for dermatomyositis in adults is exciting news for patients who previously relied on unapproved treatments,” said Octapharma USA President Flemming Nielsen.

FDA Approval

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Fall Clinical Dermatology 2020: Lilly and Incyte Showcase Positive New Data for Baricitinib in Adult Patients with Alopecia Areata

The Pharma Data

OCTOBER 29, 2020

Data support baricitinib’s ongoing Phase 3 program and potential to be the first approved medicine for people living with alopecia areata (AA). . The data underscore Lilly’s commitment to providing medicines for dermatologic diseases that have high unmet need, including alopecia areata (AA).

Dermatology

Dermatology Development Medicine Clinical Trials

Top Life Science News and Trends in 2023 at Xtalks

XTalks

DECEMBER 20, 2023

Novo Nordisk’s GLP-1 weight loss-specific drug Wegovy (semaglutide) has been facing similar shortages, as it contains the same active ingredient as Ozempic. The companies include a diverse range engaged in innovative approaches in areas like oncology, genetic medicines, inflammatory diseases, dermatology and cardiorenal therapy.

Life Science

Life Science Clinical Trials Clinical Trials FDA Approval

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) for the.

The Pharma Data

AUGUST 22, 2021

a CheckMate -274 primary investigator and Professor of Medicine, Director of Genitourinary Medical Oncology, Co-Director of the Center of Excellence for Bladder Cancer, and Associate Director for Translational Research at The Tisch Cancer Institute and the Icahn School of Medicine at Mount Sinai. Galsky,* M.D.,

Drugs

Drugs HR FDA Approval Trials

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

AUGUST 2, 2023

With each passing year, pharmaceutical companies around the globe strive to deliver cutting-edge medicines, therapies and vaccines that impact the lives of millions. In this in-depth article, we embark on a captivating journey to uncover the top 30 pharma and biotech companies that have been instrumental in shaping the future of medicine.

Sales

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FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

The Pharma Data

APRIL 4, 2023

Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who are not eligible for cisplatin-containing chemotherapy.

FDA Approval

FDA Approval Containment Hormones Dermatology

Novartis key growth drivers and launches continue momentum in Q1, maintaining confidence in growth. Group guidance for FY 2021 confirmed. | Novartis

The Pharma Data

APRIL 26, 2021

COVID-19 negatively impacted demand, particularly: dermatology, ophthalmology, the breast cancer portfolio, Sandoz Retail and Anti-Infectives. Excluding prior year COVID-19 related forward purchasing , we estimate Q1 net sales grew +1% (cc, +4% USD), with Innovative Medicines growing +3% (cc, +7% USD)².

Sales

Sales Medicine Production Manufacturing

Bristol Myers Squibb Statement on Opdivo® (nivolumab) Monotherapy Post-Sorafenib Hepatocellular Carcinoma U.S. Indication

The Pharma Data

JULY 23, 2021

The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. endocrinopathies and dermatologic reactions) are discussed below.

Hormones

Hormones Trials Genome Genomics

Safety Recommendation on Janus kinase (JAK) Inhibitors Issued in the European Union

Pfizer

OCTOBER 28, 2022

NYSE: PFE) announced today that the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has concluded their assessment of Janus kinase (JAK) inhibitors authorized for the treatment of certain inflammatory diseases in the European Union (EU) and has provided updated recommendations for their use.

Clinical Trials

Clinical Trials Clinical Trials Vaccination Vaccine

Bristol Myers Squibb Statement on Opdivo® (nivolumab) Hepatocellular Carcinoma U.S. Indication

The Pharma Data

MARCH 11, 2021

The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. endocrinopathies and dermatologic reactions) are discussed below.

Trials

Trials Hormones Genome Genomics

CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival

The Pharma Data

AUGUST 11, 2020

We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. About Opdivo.

Trials

Trials Hormones Clinical Trials Clinical Trials

CheckMate -649, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Chemotherapy vs. Chemotherapy, Meets Primary Endpoints Demonstrating Superior Overall Survival and Progression-Free Survival in First-Line Treatment of Gastric and Esophageal Cancers

The Pharma Data

AUGUST 11, 2020

We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. About Opdivo.

Trials

Trials Hormones Clinical Trials Clinical Trials

How GSK, Chiesi Farmaceutici, Regeneron/Sanofi, Novartis, and AB Science are trying to benefit patients afflicted with Inadequately Controlled Asthma?

Delveinsight

AUGUST 13, 2020

It contains fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist, delivered in GSK’s Ellipta dry powder inhaler. Conclusions : The addition of UMEC improved trough FEV, independently of baseline blood eosinophil and FeNO levels.

Antibody

Antibody Medicine Trials Development

Clinical Research Informer

Filsuvez Topical Gel Gets FDA Approval for Epidermolysis Bullosa

FDA approves Octapharma’s Octagam® 10% for adult dermatomyositis

Trending Sources

Fall Clinical Dermatology 2020: Lilly and Incyte Showcase Positive New Data for Baricitinib in Adult Patients with Alopecia Areata

Top Life Science News and Trends in 2023 at Xtalks

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) for the.

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

Novartis key growth drivers and launches continue momentum in Q1, maintaining confidence in growth. Group guidance for FY 2021 confirmed. | Novartis

Bristol Myers Squibb Statement on Opdivo® (nivolumab) Monotherapy Post-Sorafenib Hepatocellular Carcinoma U.S. Indication

Safety Recommendation on Janus kinase (JAK) Inhibitors Issued in the European Union

Bristol Myers Squibb Statement on Opdivo® (nivolumab) Hepatocellular Carcinoma U.S. Indication

CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival

CheckMate -649, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Chemotherapy vs. Chemotherapy, Meets Primary Endpoints Demonstrating Superior Overall Survival and Progression-Free Survival in First-Line Treatment of Gastric and Esophageal Cancers

How GSK, Chiesi Farmaceutici, Regeneron/Sanofi, Novartis, and AB Science are trying to benefit patients afflicted with Inadequately Controlled Asthma?

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